This study will examine the hypothesis that Gardasil® vaccination might prevent recurrence of genital warts (condylomata acuminata) caused by human papilloma virus (HPV) type 6 or 11.

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2012-004007-13-DE
• Date of registration: 06/06/2013
• Prospective Registration: Yes
• Primary sponsor: Deutsches Krebsforschungszentrum (DKFZ
• Public title: This study will examine the hypothesis that Gardasil® vaccination might prevent recurrence of genital warts (condylomata acuminata) caused by human papilloma virus (HPV) type 6 or 11.
• Scientific title: A randomized, placebo-controlled, phase IIIb HPV vaccination trial with Gardasil® in patients with recurrent condylomata acuminata - GaReCo
• Date of first enrolment: 06/09/2013
• Target sample size: 200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004007-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Germany

Contacts

• Name: Representative of the Sponsor
• Affiliation: Deutsches Krebsforschungszentrum (DKFZ)

• Name: Representative of the Sponsor
• Affiliation: Deutsches Krebsforschungszentrum (DKFZ)

Key inclusion & exclusion criteria

Inclusion criteria:
- External condylomata acuminata (at least one) defined as: condylomata acuminata, condylomata gigantea, keratotic genital warts, papular warty-like lesions within 6 months after removal of previously clinically diagnosed external condylomata acuminata (at least one)
- Willingness for single session ablation by scissor snip excision, curettage, electrocautery or laser surgery
- Age = 18
- Ability of patient to understand character and individual consequences of the clinical trial
- provision of written informed consent


Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion criteria:
- Contraindications to vaccination with Gardasil® according to the summary of product characteristics
- HIV infection or other known immune deficiency disease or current treatment with immunosuppressive drugs
- Syphilis (clinical features of first stage and second stage)
- Previous treatment with Imiquimod within the last 30 days prior to visit 1
-Previous/concomitant treatment with any other immunomodulators within the last 90 days prior to visit 1
- Previous immunization with Gardasil® or Cervarix
- Patients who are unlikely to adhere to the protocol
- Participation in other ongoing clinical trials or during their observation period
- Pregnancy (women of child bearing potential, WOCBP, will be asked before enrollment and visit 4, and a pregnancy urine test will be perofmed at visits 1-3 before study medication is applied)




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with recurrrent external condylomata acuminata located at the following genital regions: labia minora and majora, introitus vaginae, clitoris, prepuce, glans penis, coronal sulcus and frenulum, perianal skin, perineal region, inguinal- and pubes region.
MedDRA version: 20.0 Level: LLT Classification code 10010295 Term: Condylomata acuminatum System Organ Class: 100000016515

Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Intervention(s)

Trade Name: Gardasil
Product Name: Gardasil
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Intramuscular use

Primary Outcome(s)

Main Objective: Primary objective is to evaluate the efficacy of Gardasil® compared with placebo on the prevention of recurrence of condylomata acuminata.
The primary endpoint is the recurrence rate of condylomata acuminata within 6 month after the third vaccination. Recurrence is defined as (1) the presence of new lesion(s) in the area which had been treated or within 1 cm near the previously treated area and/or (2) appearance of new warts/lesions on other genital sites. All recurrences are verified by biopsy and histology.

Timepoint(s) of evaluation of this end point: The primary endpoint is the recurrence rate of condylomata acuminata within 6 month after the third vaccination.

Secondary Objective: To compare Gardasil® versus placebo with respect to:
•Time to recurrence of condylomata acuminata from the day of administration of first vaccination up to 6 months after last vaccination
•Incidence of HPV 6/11 related external condylomata acuminata
•Presence (DNA) and biological activity (RNA) of HPV6/11 and other HPV types in condylomata acuminata at visit 1 to visit 4
•HPV specific immunological outcomes (HPV antibody at visit 1 to visit 4 and T-cell responses at visit 1, visit 3 and visit 4)
•Associations between immunological and clinical outcomes
•Safety and tolerability

Primary end point(s): Recurrence is defined as (1) the presence of new lesion(s) in the area which had been treated or (2) appearance of new warts on other genital sites. All recurrences are verified by biopsy and histology.

Secondary Outcome(s)

Secondary end point(s): To compare Gardasil® versus placebo with respect to:
- Time to recurrence of condylomata acuminata from the day of administration of first vaccination up to 6 months after last vaccination
- Incidence of HPV 6/11 related external condylomata acuminata
- Presence (DNA) and biological activity (RNA) of HPV6/11 and other HPV types in condylomata acuminata at visit 1 to visit 4
- HPV specific immunological outcomes (HPV antibody at visit 1 to visit 4 and T-cell responses at visit 1 and visit 4)
- Associations between immunological and clinical outcomes
- Safety and tolerability

Timepoint(s) of evaluation of this end point: Time to recurrence of condylomata acuminata from the day of administration of first vaccination up to 6 months after last vaccination

Secondary ID(s)

NCT-2010-1090

Source(s) of Monetary Support

Deutsches Krebsforschungszentrum (DKFZ)

Ethics review

Status: Approved
Approval date:
Contact: